SCANLAN® A/C Locator® graft marker

Basic Information

• Brand Name: SCANLAN® A/C Locator® graft marker
• Primary DI: 00846159001037
• Version / Model: 1001-83
• Catalog Number: 1001-83
• Company Name: SCANLAN INTERNATIONAL INC
• Labeler DUNS: 023055619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-28
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 11bc2254-09a3-42cc-990c-0f757fb74687

Device Description

U-shaped style, silicone (1 per sterile pkg)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAB	Marker, Cardiopulmonary Bypass (Vein Marker)	Cardiovascular	870.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60867	Polymeric coronary bypass marker	A device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10846159001034	GS1	Box	10	In Commercial Distribution
Primary	00846159001037	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]